MAUDE Adverse Event Report: ALCON CLEAR CARE ; DISINFECTING SOLUTION

Device Problem Insufficient Information (3190)

Patient Problems Red Eye(s) (2038); Swelling (2091); Caustic/Chemical Burns (2549)

Event Date 11/09/2017

Event Type  No Answer Provided  

Event Description

Was unaware this contact solution clear care was not to be used like a normal disinfecting solution and placed the contact into my eye.I received chemical burns and extreme eye redness and swelling.Contact lens cleaner.

• Brand Name: CLEAR CARE
• Type of Device: DISINFECTING SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 7027523
• MDR Text Key: 92089072
• Report Number: MW5073299
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 56